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More Drug Firms Doing Follow-ups Than Thought–FDA

Susan Heavey, Reuters. September 3, 2009

More pharmaceutical companies have completed studies required by U.S. health regulators after their products were allowed on the market than previously thought, according to an analysis released on Thursday.

But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.

Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.

For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval. […]

But Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said even if companies finish such studies, the results don’t necessarily provide useful information. She said patients are not necessarily tracked as well as in trials done before approval.

“I’ve repeatedly seen longitudinal studies where more than half the patients have dropped out and nobody knows if they are alive or dead, healthy or sick,” she said. “So, the studies might be completed, and might be on time, but might not provide useful information on safety or effectiveness — which is what post-market studies are supposed to do.” […]

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